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Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers

NCT05335915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-09-05

No results posted yet for this study

Summary

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum.

Conditions

  • Nicotine Withdrawal
  • Nicotine Addiction
  • Drug Effect

Interventions

OTHER

Nicotine

Nicotine pouches will be self-administered

OTHER

Cigarette

Cigarette will be smoked

Sponsors & Collaborators

Principal Investigators

  • Tory Spindle, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-27
Primary Completion
2025-08-29
Completion
2025-08-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335915 on ClinicalTrials.gov